Kendall
Neonatal-Pediatric Monitoring Electrodes with Aloe,Prewired, Square, Reflective Backing, Radiolucent
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (6), Zhejiang (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shanghai Yuechen Medical Supply Co..ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
Showing 12 of 33. All 33 manufacturers in China registered for Electrode, Electrocardiograph
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-02-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 600, case of 300, case of 1000, pack_or_inner_pack of 1000, case of 4000, pack_or_inner_pack of 75 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 31151916 | 25 | In distribution | |
| 31151882 | 5 | In distribution | |
| 01143700 | 30 | In distribution | |
| 31151866 | 3 | In distribution | |
| 01148592 | 3 | In distribution | |
| 50007365 | 5 | In distribution | |
| ES40025 | 50 | In distribution | |
| 31424786 | 5 | In distribution | |
| ES82650 | 50 | In distribution | |
| ES82607 | 5 | In distribution | |
| 30618477 | 50 | In distribution | |
| 01148600 | 25 | In distribution | |
| 31098448 | In distribution | ||
| ES40037 | 12 | In distribution | |
| ET00095 | 100 | In distribution | |
| 01143718 | 30 | In distribution | |
| EF00145 | 100 | In distribution | |
| 2293005 | 5 | In distribution | |
| ET88110 | 100 | In distribution | |
| 222002S | 3 | In distribution | |
| MK06200 | In distribution | ||
| 10415041 | 3 | In distribution | |
| 10426865 | 25 | In distribution | |
| ES82597 | 3 | In distribution | |
| ES20211 | 50 | In distribution | |
| 31499224 | 10 | In distribution | |
| 10415033 | 30 | In distribution | |
| 31439725 | 3 | Withdrawn | |
| 31043055 | 60 | Withdrawn | |
| 222002A | 3 | Withdrawn | |
| 31478376 | 5 | Withdrawn | |
| 50007305 | 50 | Withdrawn | |
| 31115796 | 3 | Withdrawn | |
| 40000003 | 30 | Withdrawn | |
| 31424785 | 3 | Withdrawn | |
| 31078135 | 30 | Withdrawn | |
| ES82417 | 3 | Withdrawn | |
| 2293003 | 3 | Withdrawn | |
| 22735 | 5 | Withdrawn | |
| 22855 | 5 | Withdrawn | |
| 50007363 | 3 | Withdrawn | |
| ES40036 | 12 | Withdrawn | |
| 22900 | 100 | Withdrawn | |
| 22853 | 3 | Withdrawn | |
| 31115788 | 5 | Withdrawn | |
| 31424719 | 3 | Withdrawn | |
| 31452389 | 50 | Withdrawn | |
| 31013926 | 30 | Withdrawn | |
| 31043170 | 50 | Withdrawn | |
| 30951514 | Withdrawn | ||
| 31439766 | 5 | Withdrawn | |
| 31043063 | 60 | Withdrawn | |
| 22933 | 3 | Withdrawn | |
| EP30016 | 3 | Withdrawn | |
| 31424743 | 3 | Withdrawn | |
| 22450 | 50 | Withdrawn | |
| 22500 | 100 | Withdrawn | |
| EP00779 | 3 | Withdrawn | |
| 30710001 | 3 | Withdrawn | |
| 22455 | 5 | Withdrawn | |
| 22453 | 3 | Withdrawn | |
| 40000013 | 100 | Withdrawn | |
| 31447793 | 100 | Withdrawn | |
| 31424735 | 3 | Withdrawn | |
| 22930 | 30 | Withdrawn | |
| 222002 | 3 | Withdrawn | |
| EF00066 | 100 | Withdrawn | |
| ES40076 | 30 | Withdrawn | |
| 31112496 | 30 | Withdrawn | |
| 22750 | 50 | Withdrawn | |
| EP00777 | 3 | Withdrawn | |
| 31050522 | 100 | Withdrawn | |
| 30807732 | 100 | Withdrawn | |
| 22300 | 100 | Withdrawn | |
| ER88007 | 100 | Withdrawn | |
| EF00149 | 100 | Withdrawn | |
| ES40281 | 30 | Withdrawn | |
| 31424768 | 3 | Withdrawn | |
| MK06860 | Withdrawn | ||
| 22733 | 3 | Withdrawn | |
| 22700 | 50 | Withdrawn | |
| EP01350 | 4 | Withdrawn | |
| 22935 | 5 | Withdrawn | |
| 31478368 | 3 | Withdrawn | |
| 50007361 | 150 | Withdrawn | |
| 31433538 | 100 | Withdrawn | |
| 31424780 | 3 | Withdrawn | |
| 22850 | 50 | Withdrawn | |
| 31086575 | 3 | Withdrawn | |
| ES40030 | 30 | Withdrawn | |
| 31118733 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APK | APK Technology Co., Ltd. | 113 |
| Electrode, Electrocardiograph | Fiab SPA | 109 |
| Swaromed | Tyrolmed GmbH | 93 |
| MediMax Tech | Medimax Tech Inc. | 91 |
| Medline | Medline Industries, Inc. | 78 |
| AMC | LifeSync Corporation | 74 |
| Kendall | Cardinal Health 200, LLC | 73 |
| Ambu WhiteSensor | Medico Electrodes International Ltd | 51 |
| Z-Brand™ | Graphic Controls Acquisition Corporation | 48 |
| S&W | Leonhard Lang Gmbh | 47 |
| Vermed | Graphic Controls Acquisition Corporation | 45 |
| Red Dot™ | 3M Company | 44 |
Showing 12 of 337. All products under Electrode, Electrocardiograph
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.